US20070270744A1 - Limited Reuse Assembly For Ophthalmic Injection Device - Google Patents

Abstract

A limited reuse assembly for an ophthalmic medical device has an actuator with a shaft, a power source for providing power to the actuator, a controller for controlling the actuator, a mechanical linkage interface, and a housing. The mechanical linkage interface is coupled to the actuator shaft and has a mating surface on one end. The housing at least partially encloses the power source, the controller, and the actuator. The limited reuse assembly is attachable to and removable from a disposable injection device.

Description

RELATED APPLICATIONS
• This application is a continuation-in-part of U.S. patent application Ser. No. 11/581,629 filed Oct. 16, 2006, U.S. patent application Ser. No. 11/581,630 filed Oct. 16, 2006, U.S. patent application Ser. No. 11/581,591 filed Oct. 16, 2006, and U.S. patent application Ser. No. 11/435,906 filed May 17, 2006.
BACKGROUND OF THE INVENTION
• The present invention relates to a single-use medical device and more particularly to a two-piece ophthalmic drug delivery device with a disposable tip end containing an improved plunger linkage and seal.
• Several diseases and conditions of the posterior segment of the eye threaten vision. Age related macular degeneration (ARMD), choroidal neovascularization (CNV), retinopathies (e.g., diabetic retinopathy, vitreoretinopathy), retinitis (e.g., cytomegalovirus (CMV) retinitis), uveitis, macular edema, glaucoma, and neuropathies are several examples.
• These, and other diseases, can be treated by injecting a drug into the eye. Such injections are typically manually made using a conventional syringe and needle.FIG. 1 is a perspective view of a prior art syringe used to inject drugs into the eye. InFIG. 1, the syringe includes aneedle105, aluer hub110, achamber115, aplunger120, aplunger shaft125, and athumb rest130. As is commonly known, the drug to be injected is located inchamber115. Pushing on thethumb rest130 causes theplunger120 to expel the drug throughneedle105.
• In using such a syringe, the surgeon is required to puncture the eye tissue with the needle, hold the syringe steady, and actuate the syringe plunger (with or without the help of a nurse) to inject the fluid into the eye. The volume injected is typically not controlled in an accurate manner because the vernier on the syringe is not precise relative to the small injection volume. Fluid flow rates are uncontrolled. Reading the vernier is also subject to parallax error. Tissue damage may occur due to an “unsteady” injection. Reflux of the drug may also occur when the needle is removed from the eye.
• An effort has been made to control the delivery of small amounts of liquids. A commercially available fluid dispenser is the ULTRA™ positive displacement dispenser available from EFD Inc. of Providence, R.I. The ULTRA dispenser is typically used in the dispensing of small volumes of industrial adhesives. It utilizes a conventional syringe and a custom dispensing tip. The syringe plunger is actuated using an electrical stepper motor and an actuating fluid. Parker Hannifin Corporation of Cleveland, Ohio distributes a small volume liquid dispenser for drug discovery applications made by Aurora Instruments LLC of San Diego, Calif. The Parker/Aurora dispenser utilizes a piezo-electric dispensing mechanism. Ypsomed, Inc. of Switzerland produces a line of injection pens and automated injectors primarily for the self-injection of insulin or hormones by a patient. This product line includes simple disposable pens and electronically-controlled motorized injectors.
• U.S. Pat. No. 6,290,690 discloses an ophthalmic system for injecting a viscous fluid (e.g. silicone oil) into the eye while simultaneously aspirating a second viscous fluid (e.g. perflourocarbon liquid) from the eye in a fluid/fluid exchange during surgery to repair a retinal detachment or tear. The system includes a conventional syringe with a plunger. One end of the syringe is fluidly coupled to a source of pneumatic pressure that provides a constant pneumatic pressure to actuate the plunger. The other end of the syringe is fluidly coupled to an infusion cannula via tubing to deliver the viscous fluid to be injected.
• It would be desirable to have a portable hand piece for injecting a drug into the eye that includes a relatively inexpensive tip segment that can be attached to and removed from a reusable assembly. Placing the more expensive components, including electronics and a drive mechanism, in the reusable assembly, while keeping the sterile components in the tip assembly, improves the efficiency and cost-effectiveness of a drug delivery system. It would be desirable to have a reusable assembly that contains the functionally and components for the injection process. It would also be desirable to have a disposable tip segment that can be easily attached to the reusable assembly for the injection, and then easily removed and discarded after the injection. Such a system provides numerous benefits over prior art injectors.
SUMMARY OF THE INVENTION
• In one embodiment consistent with the principles of the present invention, the present invention is a limited reuse assembly having an actuator with a shaft, a power source for providing power to the actuator, a controller for controlling the actuator, a mechanical linkage interface, and a housing. The mechanical linkage interface is coupled to the actuator shaft and has a mating surface on one end. The housing at least partially encloses the power source, the controller, and the actuator. The limited reuse assembly is attachable to and removable from a disposable injection device.
• In another embodiment consistent with the principles of the present invention, the present invention is a limited reuse assembly having an actuator with a shaft, a power source for providing power to the actuator, a controller for controlling the actuator, a mechanical linkage interface, a housing, and an indicator. The mechanical linkage interface is coupled to the actuator shaft and has a mating surface on one end. The housing at least partially encloses the power source, the controller, and the actuator. The indicator is located on the housing and provides information about a status of the limited reuse assembly. The controller controls the operation of the actuator such that the actuator drives the actuator shaft to deliver a dosage of a substance into an eye.
• It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the invention as claimed. The following description, as well as the practice of the invention, set forth and suggest additional advantages and purposes of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention.
• FIG. 1 is a perspective view of a prior art syringe.
• FIG. 2 is one view of an ophthalmic medical device including a disposable tip segment and a limited reuse assembly according to an embodiment of the present invention.
• FIG. 3 is another embodiment of a limited reuse assembly according to the principles of the present invention.
• FIG. 4 is a cross section view of another embodiment of a limited reuse assembly according to the principles of the present invention.
• FIG. 5 is a cross section view of a disposable tip segment and a limited reuse assembly according to an embodiment of the present invention.
• FIG. 6 is a cross section view of a disposable tip segment for an ophthalmic medical device according to an embodiment of the present invention.
• FIG. 7 is a cross section view of a disposable tip segment for an ophthalmic medical device according to an embodiment of the present invention.
• FIG. 8 is a cross section view of a disposable tip segment and a partial view of a limited reuse assembly according to an embodiment of the present invention.
• FIG. 9A is a cross section view of a disposable tip segment for an ophthalmic medical device according to an embodiment of the present invention.
• FIG. 9B is an end view of the embodiment ofFIG. 9A.
• FIGS. 10A-10D are schematic depictions of four different circuits that may be included in embodiments of the present invention.
• FIG. 11 is end view of a limited reuse assembly according to the principles of the present invention.
• FIG. 12 is a cross section view of a limited reuse assembly according to an embodiment of the present invention.
• FIG. 13 is a cross section view of a limited reuse assembly according to an embodiment of the present invention.
• FIGS. 14 and 15 are cross section views of two subassemblies according to the principles of the present invention.
• FIG. 16 is a cross section view of a limited reuse assembly, tip segment, and a charging base according to the principles of the present invention.
• FIGS. 17A and 17B are flow charts of one method of injecting a substance into an eye according to the principles of the present invention.
• FIG. 18 is a flow chart of one method relating to injecting a substance into an eye according to the principles of the present invention.
• FIG. 19 is a flow chart of one method relating to injecting a substance into an eye according to the principles of the present invention.
• FIG. 20 is a flow chart of one method relating to injecting a substance into an eye according to the principles of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Reference is now made in detail to the exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts.
• FIG. 2 is one view of an ophthalmic medical device including a disposable tip segment and a limited reuse assembly according to an embodiment of the present invention. InFIG. 2, the medical device includes atip segment205 and alimited reuse assembly250. Thetip segment205 includes aneedle210, ahousing215, and anoptional light275. Thelimited reuse assembly250 includes ahousing255, aswitch270, alock mechanism265, and a threadedportion260.
• Tip segment205 is capable of being connected to and removed fromlimited reuse assembly250. In this embodiment,tip segment205 has a threaded portion on an interior surface ofhousing215 that screws onto the threadedportion260 oflimited reuse assembly250. In addition,lock mechanism265 securestip segment215 tolimited reuse assembly250.Lock mechanism265 may be in the form of a button, a sliding switch, or a cantilevered mechanism. Other mechanisms for connectingtip segment205 tolimited reuse assembly250, such as those involving structural features that mate with each other, are commonly known in the art and are within the scope of the present invention.
• Needle210 is adapted to deliver a substance, such as a drug, into an eye.Needle210 may be of any commonly known configuration. Preferably,needle210 is designed such that its thermal characteristics are conducive to the particular drug delivery application. For example, when a heated drug is to be delivered,needle210 may be relatively short (several millimeters) in length (for thermal purposes) to facilitate proper delivery of the drug.
• Switch270 is adapted to provide an input to the system. For example, switch270 may be used to activate the system or to turn on a temperature control device. Other switches, buttons, or user-directed control inputs are commonly known and may be employed withlimited reuse assembly250 and/ortip segment205.
• Optional light275 is illuminated whentip segment205 is ready to be used.Optional light275 may protrude fromhousing215, or it may be contained withinhousing215, in which case,optional light275 may be seen through a clear portion ofhousing215. In other embodiments,optional light275 may be replaced by an indicator, such as a liquid crystal display, segmented display, or other device that indicates a status or condition ofdisposable tip segment205. For example,optional light275 may pulse on and off to indicate other states, such as, but not limited to a system error, fully charged battery, insufficiently charged battery or faulty connection between thetip segment205 andlimited use assembly250. While shown ontip segment205,optional light275 or an additional indicator may be located onlimited reuse assembly250.
• FIG. 3 is another embodiment of a limited reuse assembly according to the principles of the present invention.Limited reuse assembly250 includes abutton308, adisplay320, and ahousing330.Disposable tip segment205 attaches to end340 oflimited reuse assembly250.Button308 is actuated to provide an input to the system. As withswitch270,button308 may activate a temperature control device or initiate actuation of a plunger.Display320 is a liquid crystal display, segmented display, or other device that indicates a status or condition ofdisposable tip segment205 orlimited reuse assembly250.
• FIG. 4 is a cross section view of another embodiment of a limited reuse assembly according to the principles of the present invention. InFIG. 4,power source505,interface517,actuator515, andactuator shaft510 are located inhousing255. The top part ofhousing255 has a threadedportion260.Lock mechanism265,switch270,button308, andindicators306,307 are all located onhousing255.
• Power source505 is typically a rechargeable battery, such as a lithium ion battery, although other types of batteries may be employed. In addition, any other type of power cell is appropriate forpower source505.Power source505 provides power to the system, and more particularly toactuator515.Power source505 also provides power to a tip segment connected tolimited reuse assembly250. In such a case,power source505 may provide power to a temperature control device (not shown) located in the tip segment. Optionally,power source505 can be removed fromhousing255 through a door or other similar feature (not shown).
• Interface517 is typically an electrical conductor that allows power to flow frompower source505 toactuator515. Other interfaces, likeinterface517, may also be present to provide power to other parts of the system.
• Actuator shaft510 is connected to and driven byactuator515.Actuator515 is typically a stepper motor or other type of motor that is capable of movingactuator shaft510 precise distances. In one embodiment,actuator shaft510 is connected via a mechanical linkage to a tip segment that delivers a drug into an eye. In such a case,actuator515 is a stepper motor that can precisely moveshaft510 to deliver a precise quantity of drug into the eye.Actuator515 is secured to an interior surface ofhousing255 by, for example, tabs that engage the outer surface ofactuator515.
• In other embodiments,actuator515 is a linear actuator or linear driver. In such a case,actuator515 may be a spring or spring driven mechanism, a geared DC motor with a rotary sensor coupled to a linear drive or a dc motor coupled to a linear drive with a linear sensor, or a linear stepper motor. Other types of motors, like a rotational permanent magnet motor, may also be used foractuator515.
• Lock mechanism265,switch270, andbutton308 are all located onhousing255 so that they can be manipulated by hand. Likewise,indicators306,307 are located onhousing255 so that they can be viewed.Lock mechanism265,switch270,button308, andindicators306,307 are also connected to a controller (not shown) via interfaces (not shown) located inhousing255.
• FIG. 5 is a cross section view of a disposable tip segment and a limited reuse assembly according to an embodiment of the present invention.FIG. 5 shows howtip segment205 interfaces withlimited reuse assembly250. In the embodiment ofFIG. 5,tip segment205 includesassembly555,plunger interface420,plunger415, dispensingchamber housing425,tip segment housing215,temperature control device450,thermal sensor460,needle210, dispensingchamber405,interface530, andtip interface connector453.Limited reuse assembly250 includesmechanical linkage interface545,actuator shaft510,actuator515,power source505,controller305, limitedreuse assembly housing255,interface535, and limited reuseassembly interface connector553.
• Intip segment205,plunger interface420 is located on one end ofplunger415. The other end ofplunger415 forms one end of dispensingchamber405.Plunger415 is adapted to slide within dispensingchamber405. The outer surface ofplunger415 is fluidly sealed to the inner surface of dispensingchamber housing425. Dispensingchamber housing425 surrounds the dispensingchamber405. Typically, dispensingchamber housing425 has a cylindrical shape. As such, dispensingchamber405 also has a cylindrical shape. Intip segment205,assembly555 includes any number of components as described below.
• Needle210 is fluidly coupled to dispensingchamber405. In such a case, a substance contained in dispensingchamber405 can pass throughneedle210 and into an eye.Temperature control device450 at least partially surrounds dispensingchamber housing425. In this case,temperature control device450 is adapted to heat and/or cool dispensingchamber housing425 and any substance contained in dispensingchamber405.Interface530 connectstemperature control device450 withtip interface connector453.
• The components oftip segment205, including dispensingchamber housing425,temperature control device450, andplunger415 are at least partially enclosed bytip segment housing215. In one embodiment consistent with the principles of the present invention,plunger415 is sealed to the interior surface of dispensingchamber housing425. This seal prevents contamination of any substance contained in dispensingchamber405. For medical purposes, such a seal is desirable. This seal can be located at any point onplunger415 or dispensingchamber housing425.
• Inlimited reuse assembly250,power source505 provides power toactuator515. An interface (not shown) betweenpower source505 andactuator515 serves as a conduit for providing power toactuator515.Actuator515 is connected toactuator shaft510. When actuator515 is a stepper motor,actuator shaft510 is integral withactuator515.Mechanical linkage interface545 is connected toactuator shaft510. In this configuration, asactuator515 movesactuator shaft510 upward towardneedle210,mechanical linkage interface545 also moves upward towardneedle210. In other embodiments of the present invention,mechanical linkage interface545 andactuator shaft510 are a single component. In other words, a shaft connected toactuator515 includes bothactuator shaft510 andmechanical linkage interface545 as a single assembly.
• Controller305 is connected viainterface535 to limited reuseassembly interface connecter553. Limited reuseassembly interface connecter553 is located on a top surface of limitedreuse assembly housing255 adjacent tomechanical linkage interface545. In this manner, both limited reuseassembly interface connector553 andmechanical linkage interface545 are adapted to be connected withtip interface connector453 andplunger interface420, respectively.
• Controller305 andactuator515 are connected by an interface (not shown). This interface (not shown) allowscontroller305 to control the operation ofactuator515. In addition, an interface (not shown) betweenpower source505 andcontroller305 allowscontroller305 to control operation ofpower source505. In such a case,controller305 may control the charging and the discharging ofpower source505 whenpower source505 is a rechargeable battery.
• Controller305 is typically an integrated circuit with power, input, and output pins capable of performing logic functions. In various embodiments,controller305 is a targeted device controller. In such a case,controller305 performs specific control functions targeted to a specific device or component, such as a temperature control device or a power supply. For example, a temperature control device controller has the basic functionality to control a temperature control device. In other embodiments,controller305 is a microprocessor. In such a case,controller305 is programmable so that it can function to control more than one component of the device. In other cases,controller305 is not a programmable microprocessor, but instead is a special purpose controller configured to control different components that perform different functions. While depicted as one component inFIG. 5,controller305 may be made of many different components or integrated circuits.
• Tip segment205 is adapted to mate with or attach tolimited reuse assembly250. In the embodiment ofFIG. 5,plunger interface420 located on a bottom surface ofplunger415 is adapted to mate withmechanical linkage interface545 located near a top surface of limitedreuse assembly housing255. In addition,tip interface connector453 is adapted to connect with limited reuseassembly interface connector553. Whentip segment205 is connected tolimited reuse assembly250 in this manner,actuator515 andactuator shaft510 are adapted to driveplunger415 upward towardneedle210. In addition, an interface is formed betweencontroller305 andtemperature control device450. A signal can pass fromcontroller305 totemperature control device450 throughinterface535, limited reuseassembly interface connector553,tip interface connector453, andinterface530.
• In operation, whentip segment205 is connected tolimited reuse assembly250,controller305 controls the operation ofactuator515. When actuator515 is actuated,actuator shaft510 is moved upward towardneedle210. In turn,mechanical linkage interface545, which is mated withplunger interface420, movesplunger415 upward towardneedle210. A substance located in dispensingchamber405 is then expelled throughneedle210.
• In addition,controller305 controls the operation oftemperature control device450.Temperature control device450 is adapted to heat and/or cool dispensingchamber housing425 and its contents. Since dispensingchamber housing425 is at least partially thermally conductive, heating or cooling dispensingchamber housing425 heats or cools a substance located in dispensingchamber405. Temperature information can be transferred fromthermal sensor460 throughinterface530,tip interface connector453, limited reuseassembly interface connector553, andinterface535 back tocontroller305. This temperature information can be used to control the operation oftemperature control device450. Whentemperature control device450 is a heater,controller305 controls the amount of current that is sent totemperature control device450. The more current sent totemperature control device450, the hotter it gets. In such a manner,controller305 can use a feed back loop utilizing information fromthermal sensor460 to control the operation oftemperature control device450. Any suitable type of control algorithm, such as a proportional integral derivative (PID) algorithm, can be used to control the operation oftemperature control device450.
• FIG. 6 is a cross section view of a disposable tip segment for an ophthalmic medical device according to an embodiment of the present invention. InFIG. 6,disposable tip segment205 includeshousing215,needle210,plunger415,plunger interface420, dispensingchamber405, dispensingchamber housing425,assembly555,temperature control device450,thermal sensor460,optional luer430,tip interface connectors451,452, and453, and interfaces461,462, and463.Disposable tip segment205 operates as a disposable injection device.
• In the embodiment ofFIG. 6,plunger415 is located in dispensingchamber housing425.Dispensing chamber405 is enclosed by dispensingchamber housing425 andplunger415.Plunger415 forms a fluid seal with the interior surface of dispensingchamber housing425.Needle210 is fluidly coupled to dispensingchamber405. In this manner, a substance located in dispensingchamber405 can be contacted byplunger415 and pushed out ofneedle210.Needle210 may be secured todisposable tip segment205 by anoptional luer430 or may be permanently attached.Temperature control device450 is located on dispensingchamber housing425 and at least partially surrounds dispensingchamber405.Housing215 forms an outer skin ondisposable tip segment205.
• In various embodiments of the present invention,temperature control device450 is a heating and/or a cooling device.Temperature control device450 is in thermal contact with dispensingchamber housing425. As such,temperature control device450 is capable of changing the temperature of the substance in dispensingchamber405.
• InFIG. 6,plunger415 includes an o-ring. The o-ring seals against an interior surface of dispensingchamber housing425. In this manner, a sterile seal is maintained thus preventing contamination of the substance in dispensingchamber405.Plunger415 may be made of any suitable material, such as, for example, glass, stainless steel, or a polymer. The o-ring is typically made of rubber or a polymer. Other types of seals may also be used. For example,plunger415 may contain an annular ring that is located around a periphery ofplunger415 so that the annular ring contacts the interior surface of dispensingchamber425. This annular ring can seal the plunger against the interior surface of dispensingchamber425. In such a case, the annular ring may be integral withplunger415, andplunger415 may be made of rubber or a polymer.Plunger interface420 may be of any suitable shape. For example, plunger interface may be substantially bowl shaped as shown, or it may be substantially flat, conical, or spherical. It may also include a lip or other similar feature.
• Tip interface connectors451,452, and453 serve to provide a connection betweentip segment205 and a limited reuse assembly.Interface461 connectsthermal sensor460 to tipinterface connector451.Interface462 connectstemperature control device450 to tipinterface connector452.Interface463 connects assembly555 to tipinterface connector453.
• Assembly555 can include any of a number of different components. In one embodiment,assembly555 contains a fuse that is blown when the heat button is activated or afterdisposable tip segment205 is used. In this manner, the fuse prevents reuse ofdisposable tip segment205. In another embodiment,assembly555 includes a memory device that stores information about the type ofdisposable tip segment205, dosage information, temperature information, plunger movement information, or any other type of information that identifies a characteristic ofdisposable tip segment205 or a manner in whichdisposable tip segment205 is operated. In other embodiments,assembly205 includes a hard-wired memory device, like a NAND flash IC, an RFID tag, a hard-wired wired circuit that can store a representation of data, like a series of fuses and resistors connected in parallel or other type of device.
• A substance to be delivered into an eye, typically a drug, is located in dispensingchamber405. In this manner, the drug is contacted by the inner surface of dispensingchamber housing425 and one face ofplunger415.Temperature control device450 is in thermal contact with dispensingchamber housing425. In this manner,temperature control device450 is adapted to control the temperature of the contents of dispensingchamber405.
• In various embodiments of the present invention,temperature control device450 heats a phase transition compound that is located in dispensingchamber405. This phase transition compound carries a drug that is to be injected into the eye. A phase transition compound is in a solid or semi-solid state at lower temperatures and in a more liquid state at higher temperatures. Such a substance can be heated bytemperature control device450 to a more liquid state and injected into the eye where it forms a bolus that erodes over time. Likewise, a reverse gelation compound may be used. A reverse gelation compound is in a solid or semi-solid state at higher temperatures and in a more liquid state at lower temperatures. Such a compound can be cooled bytemperature control device450 to a more liquid state and injected into the eye where it forms a bolus that erodes over time. As such,temperature control device450 may be a device that heats a substance in dispensingchamber405 or a device that cools a substance in dispensing chamber405 (or a combination of both). After being delivered into the eye, a phase transition compound or reverse gelation compound erodes over time providing a quantity of drug over an extended period of time. Using a phase transition compound or reverse gelation compound provides better drug dosage with fewer injections.
• Thermal sensor460 provides temperature information to assist in controlling the operation oftemperature control device450.Thermal sensor460 may be located near dispensingchamber housing425 and measures a temperature near dispensingchamber housing425.Thermal sensor460 may also be located in thermal contact with dispensingchamber housing425, in which case it measures a temperature of dispensingchamber housing425. In other embodiments, the temperature thatthermal sensor460 measures can be correlated to the temperature of the substance in dispensingchamber405. In other words, a measurement of the temperature of dispensingchamber housing425 can be used to calculate the temperature of the substance located in dispensingchamber405. Since the thermal characteristics of dispensingchamber housing425 and the substance therein are known, and the temperature oftemperature control device450 is controllable, an application of temperature control device for a specified period of time results in a calculable change in the temperature of the substance in dispensingchamber405.Thermal sensor460 may be any of a number of different devices that can provide temperature information. For example,thermal sensor460 may be a thermocouple or a resistive device whose resistance varies with temperature.
• In one embodiment of the present invention, the substance located in dispensingchamber405 is a drug that is preloaded into the dispensing chamber. In such a case,disposable tip segment205 is appropriate as a single use consumable product. Such a disposable product can be assembled at a factory with a dosage of a drug installed.
• When a drug is preloaded into dispensingchamber405, a set quantity of the drug can be preloaded. For example, 100 microliters of a drug can be loaded into dispensingchamber405, and any quantity up to 100 microliters can be dispensed. Information about the amount of drug in dispensingchamber205 and other dosage information can be stored inassembly555. In such a case,plunger415 can be moved a precise distance to deliver a precise dosage of drug from dispensingchamber405, throughneedle210, and into an eye. This provides for flexibility of dosing and for ease of assembly.
• FIG. 7 is a cross section view of a disposable tip segment for an ophthalmic medical device according to an embodiment of the present invention. InFIG. 7,disposable tip segment205 includeshousing215,needle210,plunger415,plunger interface420, dispensingchamber405, dispensingchamber housing425,assembly555,temperature control device450,thermal sensor460,optional luer430,tip interface connectors452 and453,interfaces462 and463, andlock mechanism471.
• The embodiment ofFIG. 7 functions like the embodiment ofFIG. 6. The various components oftip segment205 ofFIG. 7 have the same characteristics and operate in substantially the same way as like components ofFIG. 6.Lock mechanism471 serves to attachtip segment205 to a limited reuse assembly. A mating mechanism, likelock mechanism265, on a limited reuse assembly, attaches to lockmechanism471 and securestip segment205 to a limited reuse assembly.
• FIG. 8 is a cross section view of a disposable tip segment and a partial view of a limited reuse assembly according to an embodiment of the present invention. InFIG. 7,disposable tip segment205 includeshousing215,needle210,plunger415,plunger interface420, dispensingchamber405, dispensingchamber housing425,RFID tag1110,temperature control device450,tip interface connector452, andinterface462. The partial view of a limited reuse assembly depictsmechanical linkage interface545,actuator shaft510,interface535, limited reuseassembly interface connector552,RFID reader1120, andRFID interface1130.
• The embodiment ofFIG. 8 functions like the embodiments ofFIGS. 6 and 7. The various components of thetip segment205 ofFIG. 8 have the same characteristics and operate in substantially the same way as the like components ofFIGS. 6 and 7. However, the embodiment ofFIG. 8 uses an RFID system rather than awired assembly555 to store and transfer information.RFID reader1120 is located near the top of a limited reuse assembly adjacent tomechanical linkage interface545. RFID tag is located at the bottom oftip segment205.RFID reader1120 is designed to read information fromRFID tag1110.RFID interface1130 is connected to controller305 (not shown).
• RFID tag1110 is configured to hold the same type of information thatassembly555 may hold in the embodiments ofFIGS. 5-7. In this manner,RFID tag1110 is another type of memory. However, as is commonly know,RFID tag1110 does not require a wired connection toRFID reader1120. In this manner, a wireless connection between the tip segment205 (RFID tag1110) and a limited reuse assembly (RFID reader1120) can be established.
• In one type of RFID system, a passive RFID system,RFID tag1110 does not have a power supply. Instead, the passive RFID tag relies on the electromagnetic field produced byRFID reader1120 for its power. The electromagnetic field produced byRFID reader1120 and emitted from the RFID reader antenna (not shown) induces a small electrical current inRFID tag1110. This small electrical current allowsRFID tag1110 to operate. In this passive system the RFID tag is designed to collect power from the electromagnetic field emitted by theRFID reader1120 and to transmit an outbound signal that is received byRFID reader1120.
• In operation the RFID reader antenna (not shown) transmits a signal produced byRFID reader1120. The RFID tag antenna (not shown) receives this signal and a small current is induced inRFID tag1110. This small currentpowers RFID tag1110.RFID tag1110 can then transmit a signal through its RFID tag antenna to RFID reader antenna andRFID reader1120 itself. In this manner,RFID tag1110 andRFID reader1120 can communicate with each over a radio frequency link.RFID tag1110 transmits information, such as dosage information or tip segment information, through RFID tag antenna toRFID reader1120. This information is received byRFID reader1120. In this manner, information can be transferred from thetip segment205 to the limited reuse assembly.RFID reader1120 can transmit information toRFID tag1110 in a similar fashion. For example,RFID reader1120 can transmit information such as dosage information over the radio frequency signal emitted byRFID reader1120.RFID tag1120 receives this radio frequency signal with the information.RFID tag1110 can then store this information.
• While the embodiment ofFIG. 8 is described as having an RFID system, any other type of wireless system can be used to transfer information between alimited reuse assembly250 andtip segment205. For example a Bluetooth protocol maybe used to establish a communications link between alimited reuse assembly250 andtip segment205. Information can then be transferred between alimited reuse assembly250 and atip segment205 over this communication link. Other embodiments used to transfer information include an infrared protocol, 802.11, fire wire, or other wireless protocol.
• In one embodiment, RFID tag1110 (or assembly555) contains dosage information. Information about a proper drug dosage for a drug contained in dispensingchamber405 may be contained on RFID tag1110 (or assembly555). In such a case,controller305 can read the dosage information from RFID tag1110 (or assembly555) and operateactuator515 in a manner suitable to deliver the proper dosage. For example, 100 microliters may be contained within dispensingchamber405. Information stating that a dosage of 20 microliters is to be delivered into an eye maybe stored on RFID tag1110 (or assembly555). In such a case,controller305 reads the dosage information (that 20 microliters should be delivered into the eye) from RFID tag1110 (or assembly555).Controller305 can then operateactuator515 to deliver the 20 microliter dosage.Controller305 can causeactuator515 to moveactuator shaft510 and mechanical linkage interface545 a set distance related to a dosage of 20 microliters. In such a case,plunger415 is moved this set distance so that only 20 microliters of a drug is expelled fromneedle210 and into an eye.
• In another embodiment consistent with the principles of the present invention,controller305 may calculate a distance that plunger415 must be moved to deliver the desired dosage. For example, if dosage information corresponding to a drug dosage of 20 microliters is read from RFID tag1110 (or assembly555) bycontroller305, thencontroller305 may use this information to calculate a proper distance that plunger415 must be moved. Since the volume of dispensingchamber405 as well as the volume of a drug loaded in dispensingchamber405 is known, a distance that plunger415 must be moved to deliver that required dosage can be calculated bycontroller305. When dispensingchamber405 has a cylindrical shape, the volume of the dispensing chamber can be calculated by using the cross section area of the cylinder (the area of a circle) times the height of the dispensing chamber. This simple mathematical formula can be used to calculate the total volume of the dispensingchamber405. Since the cross section area of dispensingchamber405 is constant for any given application, the height which corresponds to a distance that plunger415 travels can be calculated for any dosage amount.
• For example, assume that 100 microliters of a drug is loaded into dispensingchamber405 and that the cross sectional area of dispensingchamber405 is ten. When dispensingchamber405 is in the shape of a cylinder, the height of that cylinder is also 10. To deliver a dosage of 20 microliters which corresponds to 20% of the total volume of dispensingchamber405, it is necessary to moveplunger415 upward toward needle210 a distance of two. In other words, a dosage of 20 microliters corresponds to 20% of the total volume of dispensingchamber405. In such a case,plunger415 should be moved upward toward needle210 a distance equal to 20% of the total height of dispensingchamber405.Controller305 can then controlactuator515 such thatactuator shaft510 drivesplunger415 upwards a distance of 20% of the total height of dispensingchamber405.
• In addition,controller305 may read information about a rate at whichplunger415 should be moved in order to properly deliver a dosage of drug. In such a case,controller305 reads information about the rate of drug delivery from RFID tag1110 (or assembly555) and uses that information to operateactuator515 to driveplunger415 at that rate. The rate at which plunger415 moves may be fixed or variable. In some applications, it may be desirable to moveplunger415 faster than in other applications. For example, when the drug contained in dispensingchamber405 is a drug that should be heated before being injected into an eye, it maybe desirable to driveplunger415 at a rate such that the heated drug does not cool and clogneedle210. In other applications, it maybe desirable to moveplunger415 slowly in order to improve the delivery of a drug contained in dispensingchamber405.
• RFID tag1110 (or assembly555) may also include any other type of information related to the delivery of a drug. For example, RFID tag1110 (or assembly555) may include information about the type of drug contained in dispensingchamber405, various characteristics of that drug, or other characteristics of a proper dosage or a proper delivery of that drug. In addition, RFID tag1110 (or assembly555) may contain safety information, information about the proper operation oftip segment205, or any other information related to the tip segment or limited reuse assembly.
• In another embodiment consistent with the principles of the present invention, a dosage may be selectable by the medical professional who is administering the drug. In such a case, an input device (not shown) located onlimited reuse assembly250 or ontip segment205 may enable a doctor to select the desired drug dosage. In such a case,controller305 receives the desired drug dosage and operatesactuator515 to moveplunger415 the required distance to deliver the desired dosage. Such a user selectable dosage scheme may be implemented simply by adding an extra input device.
• It may be desirable to include dosage information on RFID tag1110 (or assembly555) so that a dosing error is less likely to occur. In such a case, a number of different drugdelivery tip segments205 maybe manufactured and loaded with a drug at the factory. Dosage information can also be loaded onto RFID tag1110 (or assembly555) at the factory. In such a case, a number of different tip segments each with the same amount of drug contained in the dispensingchamber405 but with different dosage information stored on RFID tag1110 (or assembly555) can be manufactured and shipped. A doctor can then order thetip segment205 with the required dosage information on the RFID tag1110 (or assembly555). Packaging can be clearly labeled to identify the dosage information so that the proper dosage is administered to a patient.
• FIG. 9A is a cross section view of a disposable tip segment for an ophthalmic medical device according to an embodiment of the present invention. InFIG. 9,disposable tip segment205 includeshousing215,needle210,plunger415,plunger shaft417,plunger interface420, dispensingchamber405, dispensingchamber housing425,assembly555,temperature control device450,thermal sensor460,optional luer430,tip interface connectors452 and453,interfaces462 and463, andtabs472 and473.
• The various components oftip segment205 ofFIG. 9 have the same characteristics and operate in substantially the same way as like components ofFIGS. 5-8. The embodiment ofFIG. 9 includes twotabs472 and473 that engage slots in a limited reuse assembly. After these twotabs472 and473 are inserted into the slots, thetip assembly205 is rotated to lock it into place on a limited reuse assembly. The twotabs472 and473 may be of different shapes or sizes so as to provide a proper interface betweentip segment205 and a limited reuse assembly. When these twotabs472 and473 are shaped or sized differently, then tipsegment405 only fits on a limited reuse assembly in one orientation. In other embodiments of the present invention, different shaped or sized tabs can be used with different shaped or sized slots on different limited reuse assemblies. In this manner, a number of different limited reuse assemblies may be manufactured with different shaped or sized slots to accommodatetip segments205 with complimentary shaped or sized tabs.
• In addition, the embodiment ofFIG. 9 includes aplunger shaft417 that is connected toplunger415. In this embodiment,plunger415 may be over-molded ontoplunger shaft417.Plunger shaft417 is generally cylindrical in shape with a middle diameter that is less than a diameter on its distal and proximal ends.Plunger interface420 is a surface on the proximal end ofplunger shaft417.Plunger shaft417 is typically made of a rigid material such as stainless steel.Plunger415 is made of a rubber or polymer material. In another embodiment of the present invention, the distal end ofplunger shaft417 has a lip over which plunger415 can be applied.Plunger415 can be press-fitted ontoplunger shaft417 and is retained in place by a lip on the distal end ofplunger shaft417. This allows for easier assembly. Instead of overmolding plunger415 onto a shaft,plunger415 can be manufactured as a separate part and pushed onto the distal end ofplunger shaft417.Plunger interface420 can be of any suitable shape.
• FIG. 9B is an end view of the tip segment ofFIG. 9A.FIG. 9B depicts the end oftip segment205 farthest fromneedle210. This end interfaces with a limited reuse assembly. Pictured are housing215,plunger interface420,tip interface connectors451,452453,454,455, and456,tabs472 and473, andalignment slot481.
• In the embodiment ofFIG. 9B, one end ofplunger interface420 is not completely circular. It has a flat portion that is designed to align with a mechanical linkage interface with a similar cross-sectional shape. This optional feature is designed to allow proper alignment of a tip segment and a limited reuse assembly. In other embodiments of the present invention, the cross section view of one end ofplunger interface420 is circular.
• The embodiment ofFIG. 9B also includes anoptional alignment slot481 to assist in properly aligning a tip segment with a limited reuse assembly.Alignment slot481 interfaces with an alignment pin on a limited reuse assembly (581 as shown inFIG. 11). In another embodiment of the present invention,tabs472 and473 have different sizes. Alternatively,tabs472 and473 may have different shapes. The twotabs472 and473 also assist in aligning a tip segment with a limited reuse assembly by interfacing withslots572 and573 ofFIG. 11.
• In one embodiment consistent with the principles of the present invention, a tip segment is placed on a limited reuse assembly such thattabs472 and473 are inserted intoslots572 and573. The tip segment is then rotated with respect to the limited reuse assembly so thattabs472 and473 are retained inslots572 and573.Alignment pin581 andalignment slot481 are then properly aligned.
• Connectors451,452,453,454,455, and456 electrically link a tip segment to a limited reuse assembly.Connectors451,452,453,454,455, and456 interface withsimilar connectors551,552,553,554,557, and556, respectively, on a limited reuse assembly (as shown inFIG. 11). These connectors provide a path for signals to pass between a tip segment and a limited reuse assembly.
• FIGS. 10A-10D are schematic depictions of four different circuits that may be included in embodiments of the present invention.FIG. 10A shows one of many different configurations fortemperature control device450. InFIG. 10A,temperature control device450 is connected toconnectors452 and455. Power and/or control signals are provided totemperature control device450 throughconnectors452 and455.
• FIG. 10B shows one of many different configurations forthermal sensor460. InFIG. 10B,thermal sensor460 is connected toconnectors451 and454. Signals are received fromthermal sensor460 throughconnectors451 and454.
• FIG. 10C shows one of many different configurations for afuse1011.Fuse1011 may be contained withinassembly555 or may be implemented as shown inFIG. 10C. InFIG. 10C,fuse1011 is connected betweenconnectors453 and456. In this embodiment,fuse1011 acts to ensure that the tip assembly is a single-use device.Fuse1011 is blown when the heat button is activated or afterdisposable tip segment205 is used. As discussed, a controller in a limited reuse assembly detects when the connected tip segment has been used and directs an increased current to pass throughfuse1011 thus blowing the fuse. Whenfuse1011 is blown, the tip segment is no longer operable and must be discarded.
• FIG. 10D shows one of many different configurations forassembly555. InFIG. 10D,assembly555 is connected toconnectors453 and456. Power and/or control signals are provided toassembly555 throughconnectors453 and456.
• Many other configurations ofconnectors451,452453,454,455, and456 may be implemented. For example, while six connectors are shown, any number of connectors may be implemented. Further, any combination of different circuits may be contained in a tip segment.
• FIG. 11 is end view of a limited reuse assembly according to the principles of the present invention. The end of the limited reuse assembly shown inFIG. 11 interfaces with the end of the tip assembly shown inFIG. 9B. The end view of limited reuse assembly depicted inFIG. 11 showshousing255,mechanical linkage interface545, limited reuseassembly interface connectors551,552,553,554,557, and556,slots572 and573, andalignment pin581.
• In the embodiment ofFIG. 11, one end ofmechanical linkage interface545 is not completely circular. It has a flat portion that is designed to align with a plunger interface with a similar cross-sectional shape. This optional feature is designed to allow proper alignment of a tip segment and a limited reuse assembly. In other embodiments of the present invention, the cross section view of one end ofmechanical linkage interface545 is circular.
• The embodiment ofFIG. 11 also includes anoptional alignment slot581 to assist in properly aligning a tip segment with a limited reuse assembly.Alignment pin581 interfaces with an alignment slot on a tip segment (481 as shown inFIG. 9B). In another embodiment of the present invention,slots572 and573 have different sizes. Alternatively,slots572 and573 may have different shapes. The twoslots572 and573 also assist in aligning a tip segment with a limited reuse assembly by interfacing withtabs472 and473 of the tip segment shown inFIG. 9B.
• Connectors551,552,553,554,557, and556 electrically link a tip segment to a limited reuse assembly.Connectors551,552,553,554,557, and556 interface withconnectors451,452453,454,455, and456 on a tip segment (as shown inFIG. 9B). These connectors provide a path for signals to pass between a tip segment and a limited reuse assembly.
• FIG. 12 is a cross section view of a limited reuse assembly according to an embodiment of the present invention. InFIG. 12,limited reuse assembly250 includesmechanical linkage interface545,actuator shaft510,actuator515,power source505,controller305, limitedreuse assembly housing255,interface535, limited reuseassembly interface connector551,displacement sensor1215,power source controller444, andinductive element1225.
• Displacement sensor1215 measures the movement ofactuator shaft510. Displacement sensor may be, among other things, an optical rotary encoder, a linear encoder, a current sensing circuit (Hall sensor), a rotary potentiometer, or a linear potentiometer. In other embodiments, displacement sensor is capable of detecting ifactuator515 stalls. For example, a Hall sensor can detect an increased current draw byactuator515 that indicates a stall condition.Displacement sensor1215 may also measure back EMF fromactuator515.Displacement sensor1215 may be comprised of a single component or multiple components. In one embodiment consistent with the principles of the present invention,displacement sensor1215 includes a device to measure the distance that actuatorshaft510 travels and a device to detect ifactuator515 stalls.
• Displacement sensor1215 measures the position ofactuator shaft510. Sincemechanical linkage interface545 is connected toactuator shaft510,displacement sensor1215 also measures its position. Such adisplacement sensor1215 can be used to determine if a full dosage is delivered. Ifdisplacement sensor1215 detects thatactuator shaft510 has traveled a certain distance corresponding to a movement ofmechanical linkage interface545 andplunger415, then it is known that a certain dosage has been expelled fromneedle210. In the case where a drug is to be delivered into an eye,displacement sensor1215 provides information about the movement ofactuator shaft510 that can be used to determine if the full dosage has been delivered.
• In some cases,actuator515 may stall, thus failing to driveactuator shaft510,mechanical linkage interface545, andplunger415 the proper distance to deliver a full dosage of a drug into an eye. In such a case,displacement sensor1215 measures the distance that actuatorshaft510,mechanical linkage interface545, andplunger415 have traveled. From this distance information, a delivered amount of drug can be calculated. For example, when the dispensingchamber405 is cylindrical in shape, its circular cross-sectional area is known. The distance measured bydisplacement sensor1215 then becomes the height of the cylinder, and the volume of displacement can be easily calculated (bycontroller305, for example). This delivered amount can be communicated, along with a stall indication, via a display, such as display320 (FIG. 3).
• Displacement sensor1215 may also provide other information useful in the drug delivery process. For example, when a tip segment is connected to a limited reuse assembly,actuator shaft510 may be withdrawn or brought to a homed position for connection of a tip segment.Displacement sensor1215 can measure the movement ofactuator shaft510 to this homed position.Actuator shaft510 may be placed in a homed position to allow a tip segment to be attached to a limited reuse assembly or prior to delivery of a drug. In one embodiment, information read fromdisplacement sensor1215 is used to confirm thatactuator shaft510 is in a homed position beforeactuator515 is activated to deliver a drug into the eye.
• The embodiment ofFIG. 12 also includespower source controller444 andinductive element1225. These two components control the charging ofpower source505 whenpower source505 is, for example, a rechargeable battery.Power source controller444 includes circuitry that may perform any of a number of different functions related to the charging, monitoring, and maintenance ofpower source505. In other embodiments,power source controller444 may be implemented in or integrated intocontroller305.
• In one embodiment of the present invention, power source controller444 (orcontroller305, as the case may be) counts the number of times that limitedreuse assembly250 has been used. After the count has reached a predetermined safe number of uses,limited reuse assembly250 is disabled. Alternatively, power source controller444 (orcontroller305, as the case may be) counts the number oftimes power source505 has been charged (the number of charge cycles to whichpower source505 has been subjected). When the count reaches a predetermined threshold,limited reuse assembly250 is disabled. In other embodiments of the present invention power source controller444 (orcontroller305, as the case may be) detects fault conditions or other unsafe conditions ofpower source505 and prevents further use oflimited reuse assembly250.
• To chargepower source505, a current is induced ininductive element1225 when it is placed near another inductive element in a charging base (not shown). This induced currentcharges power source505.
• FIG. 13 is a cross section view of a limited reuse assembly according to an embodiment of the present invention. InFIG. 12,limited reuse assembly250 includesmechanical linkage interface545,actuator shaft510,actuator515,power source505,controller305, limitedreuse assembly housing255,interface535, limited reuseassembly interface connector551,displacement sensor1215,power source controller444, and chargingcontacts1235.
• In the embodiment ofFIG. 13,contacts1235 interface with contacts on a charging base (not shown) to provide power topower source505. In one embodiment,contacts1235 are a USB-type connection such as those used by portable electronic devices with docking stations. In one embodiment, a Molex® CradleCon™ connector is employed. Other types of connectors may also be used.
• FIGS. 14 and 15 are cross section views of two subassemblies according to the principles of the present invention. Each of these subassemblies depicts the path from theactuator515 to theneedle210.FIG. 14 depicts amechanical linkage interface545 that is rigidly connected toactuator shaft510, whileFIG. 15 depicts amechanical linkage assembly545 with a ball joint805. The use of ball joint805 assists in aligningmechanical linkage interface545 withplunger interface420.
• InFIG. 14,actuator515 has anactuator shaft510 that is rigidly connected tomechanical linkage interface545. Mechanical linkage interface mates withplunger interface420.Plunger415 is disposed within dispensingchamber housing425 and is sealed against an inside surface of dispensingchamber housing425.Dispensing chamber405 is bounded by an interior surface of dispensingchamber housing425 and the distal face ofplunger415.Temperature control device450 at least partially surrounds dispensingchamber housing425.Needle210 is fluidly coupled to dispensingchamber405.
• InFIG. 15,actuator515 has anactuator shaft510 that is connected toshaft810 via a ball joint.Mechanical linkage interface545 is rotatably connected toshaft810 via ball joint805. Mechanical linkage interface mates withplunger interface420.Plunger415 is disposed within dispensingchamber housing425 and is sealed against an inside surface of dispensingchamber housing425.Dispensing chamber405 is bounded by an interior surface of dispensingchamber housing425 and the distal face ofplunger415.Temperature control device450 at least partially surrounds dispensingchamber housing425.Needle210 is fluidly coupled to dispensingchamber405.
• InFIGS. 14 and 15,actuator515drives actuator shaft510 upward (in a direction towards needle210). In turn,mechanical linkage interface545 is also driven upward. Whenmechanical linkage interface545 is mated withplunger interface420,plunger420 is also moved upward. A substance contained in dispensingchamber405 is expelled throughneedle210. In this manner, motion and force is transferred fromactuator shaft510 tomechanical linkage interface545 toplunger415.
• When dispensingchamber405 contains a drug that is to be delivered into an eye, the configurations ofFIGS. 14-15 eliminate reflux when the needle is removed from the eye. Motion of theplunger415 is in a single direction (a direction that expels the drug in dispensing chamber405). Whenmechanical linkage interface545 is moved in a direction away fromneedle210, for example, after the drug has been injected into the eye, theplunger415 remains in place. Sinceplunger415 is not rigidly connected tomechanical linkage interface545,plunger415 is not retracted asmechanical linkage interface545 is retracted.
• FIG. 16 is a cross section diagram of the limited reuse assembly ofFIG. 13 and a charging base. InFIG. 16, a bottom surface oflimited reuse assembly250 interfaces with chargingbase1615. Whenlimited reuse assembly250 is resting in chargingbase1615,power source505 can be charged. After being charged,limited reuse assembly250 can be removed from chargingbase1615. In one embodiment of the present invention,limited reuse assembly250 with an attachedtip segment205 is placed in chargingbase1615 and a substance located in dispensingchamber405 is heated or cooled bytemperature control device450. In this manner, chargingbase1615 provides the power fortemperature control device450. When the substance located in dispensingchamber405 has reached the proper temperature (as determined from information from thermal sensor460),limited reuse assembly250 with attachedtip segment205 can be removed from the charging base. This savespower source505 for the injection process whenlimited reuse assembly250 and attachedtip segment205 are removed from chargingbase1615.
• FIGS. 17A and 17B are flow charts of one method of injecting a substance into an eye according to the principles of the present invention. In1705, a connection between a tip segment and a limited reuse assembly is recognized. In1710, the type of tip segment that was connected to the limited reuse assembly is identified. For example, a drug delivery tip segment or type of drug delivery tip segment may be identified. Such identification may occur by reading information from the tip segment, for example, by reading information from memory or RFID tag. In1715, dosage information is received from the tip segment. Like the information relating to the type of tip segment, dosage information may be read from a memory device in the tip segment by a controller, RFID reader, or similar device in the limited reuse assembly.
• In1720, a temperature control device is activated to alter the temperature of the substance that is located in the dispensing chamber. The substance may be heated or cooled as previously described. In addition, the heating or cooling may only take place when the tip segment and limited reuse assembly are located on a charging base. In1725, temperature information is received from a thermal sensor that is located near the dispensing chamber in which the substance is located. In1730, this temperature information is used to control the temperature control device to regulate the temperature of the substance.
• In1735, the actuator shaft is moved to a homed position. For example, the actuator shaft may be completely retracted to establish a homed position. The homed position can establish a reference point for a displacement sensor. In other words, the displacement sensor can begin measuring movement of the actuator shaft from the homed position. In1740, the actuator shaft is moved until the mechanical linkage interface (which is integral with or connected to the actuator shaft) contacts the plunger interface. In this position, any further movement of the actuator shaft results in an expulsion of the substance from the dispensing chamber. When the mechanical linkage interface is in contact with the plunger interface, the device is ready to be used to inject the substance into the eye. This step is taken before injecting the substance into the eye so that the substance can be maintained at a proper temperature for the injection. For example, the substance may be heated or cooled while the tip segment and limited reuse assembly are located on a charging base. When the tip segment and limited reuse assembly are removed from the charging base, the doctor may have a limited period of time to perform the injection before the temperature of the substance falls outside of the proper temperature range. Having the mechanical linkage interface in contact with the plunger interface allows for an injection to be performed in a short amount of time.
• In1745, an input is received indicating that the substance is to be delivered into the eye. For example the doctor may press a button that sends a signal to the controller indicating that the actuator is to be activated to deliver the substance. In1750, the dosage information is used to control the operation of the actuator to deliver the proper dosage at the proper rate. The substance is delivered into they eye only after it is in the proper temperature range. In1755, information is received from the displacement sensor. This information indicates how far the actuator shaft has traveled. The distance the actuator shaft has traveled correlates to a dosage. The further the shaft has traveled, the more the plunger has been displaced, and the greater the dosage delivered. In1760, an indication of the dosage delivered is provided. For example, a successful injection, in which the complete dosage has been successfully delivered, may be indicated by a green light or by a number (representing the amount of substance delivered in microliters). In an unsuccessful injection, the amount of substance actually delivered is displayed. In1765, reuse of the tip segment is prevented, for example, by blowing a fuse in the tip segment.
• FIG. 18 is a flow chart of one method relating to injecting a substance into an eye according to the principles of the present invention.FIG. 18 depicts a method of activating the temperature control device to heat or cool the substance located in the dispensing chamber while the tip segment and limited reuse assembly are located on a charging station. In1805, a connection between a tip segment and a limited reuse assembly is recognized. In1810, the type of tip segment is identified. In1815, dosage information is received from the tip segment. In1820, it is determined whether or not the tip segment and limited reuse assembly are located on the charging base. If they are not located on the charging base, then in1825, the system waits and returns to1820. If the tip segment and limited reuse assembly are located on the charging base, then in1830, the temperature control device is activated to alter a temperature of the substance contained in the dispensing chamber. In1835, temperature information is received from a thermal sensor. In1840, this temperature information is used to control the temperature control device.
• FIG. 19 is a flow chart of one method relating to injecting a substance into an eye according to the principles of the present invention.FIG. 19 depicts a method relating to determining whether or not the proper dosage has been delivered. In1910, the actuator is controlled based on a dosage and dosage rate information. The actuator moves the plunger to deliver the substance. In1920, information is received from the displacement sensor indicating the distance that the actuator shaft has moved. In1930, this distance information is used to determine if a proper dosage has been delivered. If the actuator shaft has moved the distance required to deliver the proper dosage, then in1940, an indication that the proper dosage has been delivered is provided. If the actuator shaft has not moved the distance required to deliver the proper dosage, then in1950, the dosage delivered is calculated based on the distance the actuator shaft has moved. In1960, an indication of the delivered dosage is provided.
• FIG. 20 is a flow chart of one method relating to injecting a substance into an eye according to the principles of the present invention.FIG. 20 relates to the situation in which the actuator shaft has stalled. In2010, the actuator is controlled based on a dosage and dosage rate information. The actuator moves the plunger to deliver the substance. In2020, data is received from a stall sensor. In2030, this data is used to determine if the actuator shaft has stalled. If the shaft has stalled, then in2040, an indication of the stall condition is provided. In2050, data is received from a displacement sensor indicating the distance that the actuator shaft moved. In2060, an indication of the delivered dosage is provided based on the distance information. If the shaft has not stalled, then in2070, an indication is provided that the proper dosage has been delivered.
• From the above, it may be appreciated that the present invention provides an improved system and methods for delivering precise volumes of a substance into an eye. The present invention provides a single use, disposable delivery device tip segment that is capable of delivering a precise dosage. The tip segment interfaces with a limited reuse assembly. The present invention is illustrated herein by example, and various modifications may be made by a person of ordinary skill in the art.
• While the present invention is described in the context of a single-use drug delivery device, the present invention encompasses any single-use medical device that interfaces with a source of electric power. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims (47)

1. A limited reuse assembly for an ophthalmic hand piece comprising:

an actuator having a shaft;

a power source for providing power to the actuator;

a controller for controlling the actuator;

a mechanical linkage interface coupled to the shaft, the mechanical linkage interface having a mating surface on an end; and

a housing at least partially enclosing the power source, the controller, and the actuator;

wherein the limited reuse assembly is attachable to and removable from a disposable injection device.

2. The assembly ofclaim 1 further comprising:

a pair of interface connectors located on an interfacing surface of the limited reuse assembly.

3. The assembly ofclaim 2 wherein the pair of interface connectors provides power to a tip segment.

4. The assembly ofclaim 2 wherein the pair of interface connectors provides power to a temperature control device.

5. The assembly ofclaim 2 wherein the pair of interface connectors connects the controller to a thermal sensor.

6. The assembly ofclaim 2 wherein the pair of interface connectors connects the controller to a memory device.

7. The assembly ofclaim 6 wherein data about a condition of a tip segment is transferred through the pair of interface connectors to the controller.

8. The assembly ofclaim 6 wherein dosage data is transferred through the pair of interface connectors to the controller.

9. The assembly ofclaim 8 wherein the dosage data is used to control the actuator.

10. The assembly ofclaim 6 wherein temperature data is transferred through the pair of interface connectors to the controller.

11. The assembly ofclaim 10 wherein the temperature data is used to control a temperature control device.

12. The assembly ofclaim 1 further comprising:

a stall sensor for detecting if the actuator is experiencing a stall condition; and

an interface for connecting the stall sensor to the controller.

13. The assembly ofclaim 1 further comprising:

a displacement sensor for measuring a distance the actuator shaft travels; and

an interface for connecting the displacement sensor to the controller.

14. The assembly ofclaim 1 wherein the power source is a battery.

15. The assembly ofclaim 1 wherein the actuator is a stepper motor.

16. The assembly ofclaim 1 wherein the actuator is a spring driven mechanism.

17. The assembly ofclaim 1 wherein the actuator shaft is rigidly connected to the mechanical linkage interface.

18. The assembly ofclaim 1 wherein the actuator shaft is coupled to the mechanical linkage interface via a ball and socket joint.

19. The assembly ofclaim 1 further comprising:

a power source controller for monitoring a condition of the power source.

20. The assembly ofclaim 1 further comprising:

electrical contacts located on a bottom surface of the limited reuse assembly, the electrical contacts for interfacing with a charging base.

21. The assembly ofclaim 20 wherein the electrical contacts are an electronic-type interface.

22. The assembly ofclaim 1 further comprising:

an inductive element located near a bottom surface of the limited reuse assembly, the inductive element for interfacing with a charging base.

23. The assembly ofclaim 1 further comprising:

an RFID reader located in the housing, the RFID reader adapted to read information from an RFID tag.

24. The assembly ofclaim 1 wherein the controller determines a distance to move the actuator shaft and mechanical linkage interface to deliver a dosage of a substance.

25. The assembly ofclaim 1 wherein the controller operates the actuator so that the actuator shaft moves at a fixed rate.

26. The assembly ofclaim 1 wherein the controller operates the actuator so that the actuator shaft moves at a variable rate.

27. The assembly ofclaim 1 further comprising:

an indicator located on the housing, the indicator for providing information about a status of the limited reuse assembly.

28. The assembly ofclaim 27 wherein the indicator is a display.

29. A limited reuse assembly for an ophthalmic hand piece comprising:

an actuator having a shaft;

a power source for providing power to the actuator;

a controller for controlling the actuator;

a mechanical linkage interface coupled to the shaft, the mechanical linkage interface having a mating surface on an end;

a pair of interface connectors located on an interfacing surface of the limited reuse assembly;

a displacement sensor for measuring a distance the actuator shaft travels;

an interface for connecting the displacement sensor to the controller;

a housing at least partially enclosing the power source, the controller, and the actuator; and

an indicator located on the housing, the indicator for providing information about a status of the limited reuse assembly.

wherein the controller controls the operation of the actuator such that the actuator drives the actuator shaft to deliver a dosage of a substance into an eye.

30. The assembly ofclaim 29 wherein the pair of interface connectors provides power to a tip segment.

31. The assembly ofclaim 29 wherein the pair of interface connectors connects the controller to a thermal sensor.

32. The assembly ofclaim 29 wherein the pair of interface connectors connects the controller to a memory device.

33. The assembly ofclaim 32 wherein data about a condition of a tip segment is transferred through the pair of interface connectors to the controller.

34. The assembly ofclaim 32 wherein dosage data is transferred through the pair of interface connectors to the controller.

35. The assembly ofclaim 34 wherein the dosage data is used to control the actuator.

36. The assembly ofclaim 29 wherein temperature data is transferred through the pair of interface connectors to the controller.

37. The assembly ofclaim 36 wherein the temperature data is used to control a temperature control device.

38. The assembly ofclaim 29 further comprising:

a stall sensor for detecting if the actuator is experiencing a stall condition; and

an interface for connecting the stall sensor to the controller.

39. The assembly ofclaim 29 wherein the power source is a battery.

40. The assembly ofclaim 29 wherein the actuator is selected from the group consisting of a stepper motor, a DC motor, a DC motor with a rotary sensor coupled to a linear drive, and a DC motor coupled to a linear drive with a linear sensor.

41. The assembly ofclaim 29 wherein the actuator is a spring driven mechanism.

42. The assembly ofclaim 29 wherein the actuator shaft is rigidly connected to the mechanical linkage interface.

43. The assembly ofclaim 29 wherein the actuator shaft is connected to the mechanical linkage interface via a ball and socket joint.

44. The assembly ofclaim 29 further comprising:

an RFID reader located in the housing, the RFID reader adapted to read information from an RFID tag.

45. The assembly ofclaim 29 wherein the controller operates the actuator so that the actuator shaft moves at a fixed rate.

46. The assembly ofclaim 29 wherein the controller operates the actuator so that the actuator shaft moves at a variable rate.

47. The assembly ofclaim 29 wherein the indicator is a display.

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